ISO 14971: Risk Management for Medical Devices

This course illustrates the application of risk management activities for medical device product safety through implementing the ISO 14971 International Standard for Risk Management. Topics in this course include: Overview, Definitions, General Requirements, Risk Assessment, Risk Control, Risk in Context, Risk Management File, and Tools. After completing this course, learners will be able to recognize how to apply risk management activities for medical device product safety.

After this course learners will be able to recognize risk management’s role towards medical devices product safety. idenitfy the elements of the risk management process. recognize the purpose and content for the risk management plan and report. identify tools that may be applicable to use in the risk management process. recognize risk management tasks that are applied at various stages of the product lifecycle.